Clinical Study Schedule of Activities
1.0.0 - trial-use

Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

## Resource Profile: ResearchStudySoa

Official URL: http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa | Version: 1.0.0
Active as of 2023-04-18 | Computable Name: ResearchStudySoa

A profile that lists the data elements of a Research Study that must be supported when used to schedule activities.

Usage:

- Examples for this Resource Profile: ResearchStudy/H2Q-MC-LZZT-ResearchStudy

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from ResearchStudy

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
ResearchStudy |  | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge
identifier | S | 0..* | Identifier | Business Identifier for study
title | S | 0..1 | string | Name for this study
protocol | S | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study
status | S | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
primaryPurposeType | S | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
phase | S | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
category | S | 0..* | CodeableConcept | Classifications for the study
focus | S | 0..* | CodeableConcept | Drugs, devices, etc. under study
condition | S | 0..* | CodeableConcept | Condition being studied
contact | S | 0..* | ContactDetail | Contact details for the study
relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies
keyword | S | 0..* | CodeableConcept | Used to search for the study
description | S | 0..1 | markdown | What this is study doing
sponsor | S | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study
principalInvestigator | S | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study
reasonStopped | S | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
arm | S | 0..* | BackboneElement | Defined path through the study for a subject
name | S | 1..1 | string | Label for study arm
type | S | 0..1 | CodeableConcept | Categorization of study arm
description | S | 0..1 | string | Short explanation of study path
objective | S | 0..* | BackboneElement | A goal for the study
name | S | 0..1 | string | Label for the objective
type | S | 0..1 | CodeableConcept | primary | secondary | exploratory
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
ResearchStudy |  | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..* | Identifier | Business Identifier for study
title | S Σ | 0..1 | string | Name for this study
protocol | S Σ | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study
status | ?!S Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | S Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase | S Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category | S Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus | S Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition | S Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact | S Σ | 0..* | ContactDetail | Contact details for the study
relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies
keyword | S Σ | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
description | S | 0..1 | markdown | What this is study doing
sponsor | S Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study
principalInvestigator | S Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study
reasonStopped | S Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
arm | S | 0..* | BackboneElement | Defined path through the study for a subject
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 1..1 | string | Label for study arm
type | S | 0..1 | CodeableConcept | Categorization of study arm
description | S | 0..1 | string | Short explanation of study path
objective | S | 0..* | BackboneElement | A goal for the study
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 0..1 | string | Label for the objective
type | S | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.status | required | ResearchStudyStatus
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType
ResearchStudy.phase | example | ResearchStudyPhase
ResearchStudy.category | example |
ResearchStudy.focus | example |
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes
ResearchStudy.keyword | example |
ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
ResearchStudy |  | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..* | Identifier | Business Identifier for study
title | S Σ | 0..1 | string | Name for this study
protocol | S Σ | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study
partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study
status | ?!S Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | S Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase | S Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category | S Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus | S Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition | S Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact | S Σ | 0..* | ContactDetail | Contact details for the study
relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies
keyword | S Σ | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description | S | 0..1 | markdown | What this is study doing
enrollment | Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria
period | Σ | 0..1 | Period | When the study began and ended
sponsor | S Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study
principalInvestigator | S Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study
site | Σ | 0..* | Reference(Location) | Facility where study activities are conducted
reasonStopped | S Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note |  | 0..* | Annotation | Comments made about the study
arm | S | 0..* | BackboneElement | Defined path through the study for a subject
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 1..1 | string | Label for study arm
type | S | 0..1 | CodeableConcept | Categorization of study arm
description | S | 0..1 | string | Short explanation of study path
objective | S | 0..* | BackboneElement | A goal for the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 0..1 | string | Label for the objective
type | S | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
ResearchStudy.status | required | ResearchStudyStatus
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType
ResearchStudy.phase | example | ResearchStudyPhase
ResearchStudy.category | example |
ResearchStudy.focus | example |
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes
ResearchStudy.keyword | example |
ResearchStudy.location | extensible | Jurisdiction ValueSet
ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from ResearchStudy

Summary

Must-Support: 23 elements

Structures

This structure refers to these other structures:

- StudyProtocolSoa (http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyProtocolSoa)

Differential View

This structure is derived from ResearchStudy

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
ResearchStudy |  | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge
identifier | S | 0..* | Identifier | Business Identifier for study
title | S | 0..1 | string | Name for this study
protocol | S | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study
status | S | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
primaryPurposeType | S | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
phase | S | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
category | S | 0..* | CodeableConcept | Classifications for the study
focus | S | 0..* | CodeableConcept | Drugs, devices, etc. under study
condition | S | 0..* | CodeableConcept | Condition being studied
contact | S | 0..* | ContactDetail | Contact details for the study
relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies
keyword | S | 0..* | CodeableConcept | Used to search for the study
description | S | 0..1 | markdown | What this is study doing
sponsor | S | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study
principalInvestigator | S | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study
reasonStopped | S | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
arm | S | 0..* | BackboneElement | Defined path through the study for a subject
name | S | 1..1 | string | Label for study arm
type | S | 0..1 | CodeableConcept | Categorization of study arm
description | S | 0..1 | string | Short explanation of study path
objective | S | 0..* | BackboneElement | A goal for the study
name | S | 0..1 | string | Label for the objective
type | S | 0..1 | CodeableConcept | primary | secondary | exploratory
Documentation for this format

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
ResearchStudy |  | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..* | Identifier | Business Identifier for study
title | S Σ | 0..1 | string | Name for this study
protocol | S Σ | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study
status | ?!S Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | S Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase | S Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category | S Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus | S Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition | S Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact | S Σ | 0..* | ContactDetail | Contact details for the study
relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies
keyword | S Σ | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
description | S | 0..1 | markdown | What this is study doing
sponsor | S Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study
principalInvestigator | S Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study
reasonStopped | S Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
arm | S | 0..* | BackboneElement | Defined path through the study for a subject
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 1..1 | string | Label for study arm
type | S | 0..1 | CodeableConcept | Categorization of study arm
description | S | 0..1 | string | Short explanation of study path
objective | S | 0..* | BackboneElement | A goal for the study
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 0..1 | string | Label for the objective
type | S | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.status | required | ResearchStudyStatus
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType
ResearchStudy.phase | example | ResearchStudyPhase
ResearchStudy.category | example |
ResearchStudy.focus | example |
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes
ResearchStudy.keyword | example |
ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
ResearchStudy |  | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..* | Identifier | Business Identifier for study
title | S Σ | 0..1 | string | Name for this study
protocol | S Σ | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study
partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study
status | ?!S Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | S Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase | S Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category | S Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus | S Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition | S Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact | S Σ | 0..* | ContactDetail | Contact details for the study
relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies
keyword | S Σ | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description | S | 0..1 | markdown | What this is study doing
enrollment | Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria
period | Σ | 0..1 | Period | When the study began and ended
sponsor | S Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study
principalInvestigator | S Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study
site | Σ | 0..* | Reference(Location) | Facility where study activities are conducted
reasonStopped | S Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note |  | 0..* | Annotation | Comments made about the study
arm | S | 0..* | BackboneElement | Defined path through the study for a subject
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 1..1 | string | Label for study arm
type | S | 0..1 | CodeableConcept | Categorization of study arm
description | S | 0..1 | string | Short explanation of study path
objective | S | 0..* | BackboneElement | A goal for the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 0..1 | string | Label for the objective
type | S | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
ResearchStudy.status | required | ResearchStudyStatus
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType
ResearchStudy.phase | example | ResearchStudyPhase
ResearchStudy.category | example |
ResearchStudy.focus | example |
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes
ResearchStudy.keyword | example |
ResearchStudy.location | extensible | Jurisdiction ValueSet
ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from ResearchStudy

Summary

Must-Support: 23 elements

Structures

This structure refers to these other structures:

- StudyProtocolSoa (http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyProtocolSoa)

Other representations of profile: CSV, Excel, Schematron